BD¿ PLASMA COUNT KIT
Report
- Report Number
- 2647876-2021-00355
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Date of Event
- September 7, 2021
- Report Date
- December 21, 2021
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: SCOPE OF ISSUE AND PROBLEM STATEMENT: CUSTOMER REPORTED THAT PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 HAVE PERFORMANCE ISSUE OF LOW SIGNAL. CUSTOMERS DESCRIBE THE WBC CONTROL IS MOSTLY BELOW MINIMUM, THEY CAME WITH 1.92 WBC/UL AND THEIR TARGET VALUE IS 3 WBC/UL, WHILE PREVIOUSLY USED BATCH WAS 3.01 WBC/UL. MANUFACTURING DEFECT TREND: PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 WAS ASSEMBLED IN BDB SAN JOSE (PLANT 1149) USING MATERIAL SUBASSEMBLY 91-0786 (BD TRUCOUNT TUBES) BATCH 21116 MANUFACTURED IN BDB CAYEY (PLANT 1157) AND MATERIAL SUBASSEMBLY 91-0666PR (GLYCOPHORIN A FITC / CD41A PERCP-CY5.5) BATCH 1145235 MANUFACTURED IN PLANT 1157. MATERIAL 91-0666PR BATCH 1145235 WAS USED TO MANUFACTURE MATERIAL 338331 LOT 1173989 (235 EA). NO OTHER PRODUCTS HAVE BEEN MANUFACTURED USING SUBASSEMBLY 91-0666PR BATCH 1145235 AS OF 06-DEC-21. INVESTIGATION FOCUSED ON GLYCOPHORIN A FITC / CD41A PERCP-CY5.5 REAGENT COMPONENT UNDER MATERIAL SUBASSEMBLY 91-0666PR BATCH 1145235, WHICH CONTAIN TWO ANTIGEN-SPECIFIC ANTIBODIES (GLYCOPHORIN A FITC AND CD41A PERCP-CY5.5) FOR STAINING SAMPLES. MATERIAL 91-0666PR BATCH 1145235 WAS MANUFACTURED ACCORDING TO REQUIREMENTS AND MET MANUFACTURING AND QA ACCEPTANCE CRITERIA FOR RELEASE. NO DISCREPANCIES (OOS OR QN) WERE IDENTIFIED IN MANUFACTURING/TESTING BATCH HISTORY RECORD (BHR) OF SUBASSEMBLY 91-0666PR BATCH 1145235 DURING EVALUATED PERIOD OF 12-NOV-20 TO 12-NOV-21. ROOT CAUSE ANALYSIS: ROOT CAUSE CANNOT BE DETERMINED. CUSTOMER INDICATES PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 HAVE PERFORMANCE ISSUE OF LOW SIGNAL. EVIDENCE DEMONSTRATES MANUFACTURING PROCESS WAS PERFORMED ACCORDING TO REQUIREMENTS; PRODUCT MET RELEASE SPECIFICATIONS WITHOUT DISCREPANCY AND LATER USED SATISFACTORILY AS REFERENCE LOT UNDER 91-0666PR BATCH 1145235 FOR QC RELEASE TEST OF NEWER SUBASSEMBLY 91-0666PR BATCH 1210964 ON 13-AUG-21. WFI TASK PR# 4076719 RESPONSE INDICATE THE REPORTED ISSUE WAS RESOLVED BY BDB APPLICATIONS SPECIALIST IN-SITE WITH CUSTOMER, HENCE ISSUE WAS FIXED. COMPLAINT HISTORY REVIEW: ONLY ONE (1) COMPLAINT FOR PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 OR SUBASSEMBLY 91-0666PR BATCH 1145235 RELATED TO PERFORMANCE ISSUE OF LOW SIGNAL HAVE BEEN REPORTED IN TRACKWISE DURING EVALUATED PERIOD OF 12-NOV-20 TO 12-NOV-21. IT IS NOTED THERE IS NO ADDITIONAL COMPLAINTS REPORTED AGAINST PRODUCT 338331 LOT 1173989 FROM A TOTAL OF 235 EA SOLD TO MARKET. RISK REVIEW: RISK ANALYSIS APPLICABLE FOR PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) IS AVAILABLE UNDER FAILURE MODE EFFECT ANALYSIS (FMEA) DOCUMENT 338331FMEA (REV.2). EVALUATION WAS BASED ON INFORMATION HAZARDS, WHICH MIGHT TRIGGER A PROBLEM TO CUSTOMER TO PROPERLY PERFORM TESTING WHILE USING REAGENT. HAZARD(S) IDENTIFIED? X YES NO. REVIEWED ITEM:1. REAGENT MIXTURE. POTENTIAL FUNCTION FAILURE: 2. NOT TO PERFORM TO SPEC/CLAIM. POTENTIAL EFFECT OF FAILURE: 3. WRONG RESULT - NO MATCHING PROFILE; CUSTOMER INCONVENIENCES - ADDITIONAL TESTING, COST AND TIME. POTENTIAL CAUSE OF FAILURE: 9. IMPROPER USE - INCORRECT REACTION TIME AND TEMP AT CUSTOMER SITE. 10. INCORRECT VOLUME USED AT CUSTOMER SITE. VOLUME TOO LOW.. CURRENT CONTROLS: FOR 9 = 1. LABELING, AND 2. CUSTOMER EDUCATION. FOR 10 = 1. CUSTOMER EDUCATION PROGRAM, AND 2. LABELING - DETAILED PROCEDURES. SEVERITY: FOR 9 = 7 FOR 10 = 7 OCCURRENCE: FOR 9 = 3 FOR 10 = 5 DETECTION: FOR 9 = 3 FOR 10 = 2 RISK PRIORITY NUMBER (RPN): FOR 9 = (7)(3)(3) = 63 FOR 10 = (7)(5)(2) = 70 RISK EVALUATION: RPN < 90 = ACCEPTABLE IMPLEMENTATION VERIFICATION: TECHNICAL DATA SHEET = IFU 23-7739-03 NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES NO. BATCH HISTORY RECORD (BHR) REVIEW: PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 WAS ASSEMBLED IN PLANT 1149 USING MATERIAL SUBASSEMBLY 91-0666PR BATCH 1145235 MANUFACTURED IN PLANT 1157, WHICH MET ESTABLISHED ACCEPTANCE CRITERIA FOR PRODUCT RELEASE THRU FLUOROMETRY, AGFC, AND FLOW CYTOMETRY TESTING AGAINST THREE DIFFERENT BLOOD DONOR SAMPLES, AS DEMONSTRATED BY EVALUATED BATCH HISTORY RECORD (BHR) FOLLOWING QUALITY CONTROL (QC) DOCUMENT SJ91-0666PRQC-PR-06 (REV.1), SJ91-0666PRQC-PR-07 (REV.1), AND SJ91-0666PRQC-PR-03 (REV.2), RESPECTIVELY. MANUFACTURING WAS PERFORMED ACCORDING TO REQUIREMENTS AND MET SPECIFICATIONS WITHOUT ANY DISCREPANCY OR NONCONFORMANCE. PRODUCT 338331 LOT 1173989 EXPIRES ON 31-DEC-2021. RETURNED SAMPLE ANALYSIS: SAMPLES WERE NOT REQUESTED TO BE RETURNED, SINCE QA RETAINS ARE KEPT FOR SUBASSEMBLY 91-0666PR BATCH 1145235, IF NEEDED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED TO CUSTOMER UNDER WFI TASK PR# 4076719, AIMING TO CLARIFY QUESTIONS AND OBTAIN INFORMATION IN SUPPORT TO THIS INVESTIGATION. REFER TO INVESTIGATION SUMMARY FOR DETAILS. RETAIN SAMPLE ANALYSIS: NO RETAIN SAMPLE TESTING DEEMED NECESSARY AT THIS TIME. ADDITIONAL INFORMATION AND DATA REQUESTED UNDER WFI TASK PR# 4076719. REFER TO INVESTIGATION SUMMARY SECTION FOR DETAILS. INVESTIGATION SUMMARY: CUSTOMER REPORTED PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 HAVE PERFORMANCE ISSUE OF LOW SIGNAL. AS INITIAL CLAIM REPORT DID NOT INDICATE DETAILS OF WHAT SPECIFIC PROBLEM WAS EXPERIENCED BY CUSTOMER AND DID NOT INCLUDED DATA USING BD PLASMA COUNT PRODUCT, ADDITIONAL INFORMATION WAS REQUESTED UNDER WFI TASK PR# 4076719, TO CLARIFY QUESTIONS AND UNDERSTAND PROBLEM IN SUPPORT TO THIS INVESTIGATION. AS PER PRODUCT INSTRUCTION FOR USE (IFU) 23-7739-03, PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) IS INTENDED FOR IN VITRO DIAGNOSTIC USE TO IDENTIFY AND ENUMERATE RESIDUAL LEUCOCYTES (RWBCS), RED BLOOD CELLS (RRBCS), AND PLATELETS (RPLTS) IN FRESH HUMAN PLASMA, USING FLOW CYTOMETRY. THE QUALITY OF FRESH FROM PLASMA (FFP) CAN BE DETERMINED BY COUNTING RWBCS, RRBCS, AND RPLTS PRIOR FREEZING. THE BD PLASMA COUNT ASSAY INCORPORATES BD TRUCOUNT TUBES TO DETERMINE ABSOLUTE CELL COUNTS OF RWBCS, RRBCS, AND RPLTS USING A SINGLE TUBE. PROCEDURE: A SINGLE-TUBE ASSAY IS PERFORMED BY STAINING A KNOWN VOLUME OF PLASMA SAMPLE WITH BD PLASMA COUNT REAGENTS IN AN INDIVIDUAL BD TRUCOUNT TUBE. FLUOROCHROME-LABELED ANTIBODIES BIND SPECIFICALLY TO CELL-SURFACE ANTIGENS, WHILE THE NUCLEIC ACID DYE STAINS DNA AND RNA OF ALL NUCLEATED CELLS. THE LYOPHILIZED PELLET IN THE BD TRUCOUNT TUBE DISSOLVES, RELEASING A KNOWN NUMBER OF FLUORESCENT BEADS. DURING ANALYSIS, ABSOLUTE NUMBER (CELLS/UL) OF RESIDUAL CELLS IN SAMPLE CAN BE DETERMINED BY DIVIDING NUMBER OF RESIDUAL CELLULAR EVENTS BY THE NUMBER OF FLUORESCENT BEADS EVENTS, AND THEN MULTIPLYING THE RESULT BY THE BD TRUCOUNT BEAD CONCENTRATION. REAGENT BD PLASMA COUNT KIT CONTAINS BD PLASMA COUNT REAGENT AND BD TRUCOUNT TUBES, SUFFICIENT FOR 50 TESTS. BD PLASMA COUNT KIT CONTAINS THE FOLLOWING COMPONENTS, EACH REAGENT IS PROVIDED IN PHOSPHATE-BUFFERED SALINE (PBS) WITH STABILIZER AND 0.1% SODIUM AZIDE: REAGENT VIAL A: ¿ THIAZOLE ORANGE IN STABILIZATION BUFFER. REAGENT VIAL B: ¿ FITC-LABELED CD235A, CLONE GAR-2 (HIR-2), AND ¿ PERCP-CY5.5-LABELED CD41A, CLONE HIP8, PRE-TITRATED IN STABILIZATION BUFFER. BD TRUCOUNT TUBES: ¿ EACH CONTAINING A LYOPHILIZED PELLET OF 4.2 UM FLUORESCENT-DYED BEADS. THIAZOLE ORANGE IS A NUCLEIC ACID DYE THAT PENETRATES CELL MEMBRANES AND BINDS WITH RNA AND DNA. ANTI-GLYCOPHORIN A (CD235) REACTS WITH MAJOR SIALOGLYCOPROTEIN PRESENT ON HUMAN ERYTHROCYTES MEMBRANE. ANTI-GLYCOPHORIN A IS COMPOSED OF MOUSE IGG2B HEAVY CHAINS AND KAPPA LIGHT CHAINS. GLYCOPHORIN A IS EXPRESSED ON HUMAN RED BLOOD CELLS, NORMOBLASTS AND ERYTHROID PRECURSOR CELLS. MATURE NON-NUCLEATED RED BLOOD CELLS ARE CHARACTERISTICALLY GLYCOPHORIN A POSITIVE BUT CD45 NEGATIVE. CD41A RECOGNIZES THE CALCIUM-DEPENDENT GPIIB/IIIA COMPLEXM WITH MOLECULAR WEIGHT OF 140 KDA. THIS COMPLEX IS FOUND ON PLATELETS AND PLATELET PRECURSORS. THE CD41A ANTIBODY IS COMPOSED OF MOUSE IGG1 HEAVY CHAINS AND KAPPA LIGHT CHAINS. PRECAUTIONS ¿ FOR IN VITRO DIAGNOSTIC USE. ¿ THE ADDITION OF PRECISE VOLUME OF SAMPLE IS CRITICAL. PIPETS MUST BE CALIBRATED TO DELIVER EXACTLY 25 UL AND 50 UL OF SAMPLE. IF NECESSARY, PERFORM REVERSE PIPETTING TECHNIQUE ACCORDING TO MANUFACTURER. ¿ CARE SHOULD BE TAKEN TO AVOID MICROBIAL CONTAMINATION, WHICH COULD CAUSE ABERRANT RESULTS. ¿ DO NOT USE REAGENT IF YOU OBSERVE ANY CHANGE IN APPEARANCE. ¿ BEFORE USE, INSPECT BD TRUCOUNT TUBES. IT IS CRITICAL TO USE BEAD COUNT SHOWN ON THE LOT OF BD TRUCOUNT TUBES THAT YOU ARE CURRENTLY USING WHEN CALCULATING ABSOLUTE COUNTS. DO NOT MIX MULTIPLE LOTS OF TUBES IN THE SAME ASSAY. STORAGE AND HANDLING: ¿ STORE BD PLASMA COUNT KIT AT 2-8 °C. DO NOT USE AFTER EXPIRATION DATE SHOWN ON LABEL. ¿ AVOID UNNECESSARY EXPOSURE OF THE REAGENT TO LIGHT. ¿ DO NOT FREEZE REAGENTS OR EXPOSE TO DIRECT LIGHT DURING STORAGE OR INCUBATION WITH CELLS. KEEP REAGENT VIALS DRY. ¿ STORE BD TRUCOUNT TUBES IN THEIR ORIGINAL FOIL POUCH AT 2-25 °C. EXAMINE DESICCANT EACH TIME YOU OPEN THE POUCH. IF DESICCANT TURNED FROM BLUE TO LAVENDER, DISCARD THE REMAINING TUBES. USE TUBES WITHIN 1 HOUR AFTER REMOVAL FROM FOIL POUCH. ONCE FOIL POUCH HAS BEEN OPENED, THE TUBES ARE STABLE FOR 1 MONTH. DO NOT USE BEYOND THE EXPIRATION DATE INDICATED IN PACKAGING. SPECIMEN COLLECTION AND PREPARATION: A MINIMUM OF 200UL PLASMA IS REQUIRED FOR PROCEDURE. FOR RESIDUAL CELL ENUMERATION, USE PLASMA SAMPLES WITH ADDITIVE, OR FRESH PLASMA SAMPLES WITH NO ADDITIVE WITHIN 18 HOURS OF COLLECTION. STORE PLASMA SAMPLES WITH NO ADDITIVE AT ROOM TEMPERATURE (20-25 °C) UNDER CONSTANT AGITATION UNTIL READY FOR STAINING. INTERFERING CONDITIONS: ¿ DO NOT USE PREVIOUSLY FIXED AND STORED PLASMA. ¿ SAMPLES WITHOUT ADDITIVE THAT ARE REFRIGERATED BEFORE STAINING COULD GIVE ABERRANT RESULTS. ¿ HEMOLYZED, LIPEMIC, OR CLOTTED SAMPLES SHOULD BE REJECTED. ¿ RBC AGGLUTINATION IN STAINED SAMPLES INCREASES DURING STORAGE. THEREFORE, ACQUIRE SAMPLES WITHIN 1 HOUR OF STAINING. NOTE: TO ENSURE THOROUGH RESUSPENSION OF CELLS AND BEADS, GENTLY VORTEX SAMPLES IMMEDIATELY BEFORE ACQUISITION. LIMITATIONS ¿ PERFORMANCE HAS NOT BEEN ESTABLISHED ON STREAM-IN-AIR CYTOMETER SYSTEMS. ¿ THE ADDITION OF PRECISE VOLUME OF BLOOD IS CRITICAL WHEN BD TRUCOUNT TUBES ARE USED. PIPET SHOULD BE CALIBRATED TO DELIVER 25 UL OR 50 UL OF SAMPLE. ¿ GENTLY VORTEX SAMPLES IMMEDIATELY PRIOR TO RUNNING THEM ON FLOW CYTOMETER TO ENSURE THOROUGH RESUSPENSION OF CELLS AND BEADS. ¿ NUCLEATED RED CELLS CONTAIN NUCLEIC ACID AND COULD BE DETECTED AS RWBCS IN THIS ASSAY. HOWEVER, NUCLEATED RED CELLS ARE NOT PRESENT IN DETECTABLE QUANTITIES IN BLOOD FROM NORMAL INDIVIDUALS. ¿ AS FOR ANY ASSAY INVOLVES COUNTING STATISTICS, THE NUMBER OF EVENTS COUNTED COULD INFLUENCE THE RESULT. WE RECOMMEND COLLECTING AT LEAST 100,000 TOTAL EVENTS WHEN ANALYZING LEUCOREDUCED PLASMA OR AT LEAST 10,000 BD TRUCOUNT BEADS FOR LEUCOCYTE-DEPLETED PLASMA. ¿ SAMPLES CONTAINING >38,000 RPLT HAVE NOT BEEN VALIDATED WITH THIS ASSAY. PRECISION OF BD PLASMA COUNT ASSAY FOR EACH CONCENTRATION LEVEL IS SHOWN IN TABLE 2, PAGE 21. TROUBLESHOOTING --> MAJOR PROBLEMS, POSSIBLE CAUSE AND SOLUTION ARE LISTED. REFER TO IFU 23-7739-03 PAGE 36. BASED ON INVESTIGATION FINDINGS INCLUDING EVALUATION OF WFI TASK RESPONSE INDICATING ISSUE WAS FIXED WITH CUSTOMER THRU BDB APPLICATIONS SPECIALIST, NO ADDITIONAL CLAIMS REPORTED AGAINST PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 OR SUBASSEMBLY 91-666PR BATCH 1145235, AND EVIDENCE OF NO DISCREPANCIES FOUND ON EVALUATED BHR, THIS CLAIM IS NOT CONFIRMED, AND NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS TIME. CONCLUSION: PRODUCT 338331 (BD PLASMA COUNT KIT, IVD) LOT 1173989 MANUFACTURED FROM SUBASSEMBLY 91-0666PR BATCH 1145235, WAS MANUFACTURED IN COMPLIANCE WITH BD SPECIFICATIONS. BASED ON INVESTIGATION PERFORMED IT IS DETERMINED CLAIM IS NOT CONFIRMED AND NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD¿ PLASMA COUNT KIT PRODUCED 8 LOW REAGENT SIGNALS WHERE THE CONTROL VALUES WERE BELOW MINIMUM AT 1.92 WBC/L. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE WBC CONTROL IS MOSTLY BELOW MINIMUM. WITH A TARGET VALUE OF 3 WBC/L, WE CAME UP WITH 1.92 WBC/L IN CONTRAST TO THE PREVIOUSLY USED BATCH (MEAN VALUE 3.01 WBC/L), WHICH IS COMPLETELY UNACCEPTABLE AND CAUSES US CONSIDERABLE PROBLEMS IN THE ROUTINE."
IT WAS REPORTED THAT THE BD¿ PLASMA COUNT KIT PRODUCED 8 LOW REAGENT SIGNALS WHERE THE CONTROL VALUES WERE BELOW MINIMUM AT 1.92 WBC/L. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE WBC CONTROL IS MOSTLY BELOW MINIMUM. WITH A TARGET VALUE OF 3 WBC/L, WE CAME UP WITH 1.92 WBC/L IN CONTRAST TO THE PREVIOUSLY USED BATCH (MEAN VALUE 3.01 WBC/L), WHICH IS COMPLETELY UNACCEPTABLE AND CAUSES US CONSIDERABLE PROBLEMS IN THE ROUTINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1872023 | BD¿ PLASMA COUNT KIT | NA | GKZ | BECTON DICKINSON CARIBE LTD. | 1173989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |